Abstract

ANALYTICAL METHODS DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE AND METFORMIN HYDROCHLORIDE IN SYNTHETIC MIXTURE

Abhay Thakkar, Mr. Ronak N. Patel, Dr. Divyakant Patel, Dr. Jaymin G. Patel, Dr. Bhumi R. Patel

Abstract

The objective of this study was to develop and validate accurate, precise, and reliable RP-HPLC methods for the simultaneous estimation of Esomeprazole Magnesium Trihydrate and Metformin Hydrochloride in a synthetic mixture as per ICH guidelines. Identification tests such as melting point, solubility, FT-IR were performed. In the RP-HPLC method, a mobile phase of phosphate buffer and acetonitrile (60:40 v/v, pH 3) was used. Retention times were found to be 2.3 min for Esomeprazole and 5 min for Metformin. The method showed excellent linearity, precision, and accuracy with correlation coefficients close to 1. Recovery studies were within acceptable limits. Low LOD and LOQ values indicated high sensitivity. Percentage assay values were near 100%, confirming the reliability of the developed method. No interference from excipients was observed. The developed RPHPLC method was found to be accurate, precise, economical, and reproducible. This method is suitable for routine quality control analysis of Esomeprazole Magnesium Trihydrate and Metformin Hydrochloride in synthetic mixtures.

Keywords: Esomeprazole Magnesium Trihydrate, Metformin Hydrochloride, Synthetic Mixture, RP-HPLC Method Development and Validation.